MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS-9008

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

The device was implanted via l-p shunt to the patient on (b)(6) 2014.The initial pressure settings are unknown.It was found that the devices have turned over after mri scanning on (b)(6) 2016.The surgeon tried to change setting many times but the device couldn¿t work properly.The surgeon replace with another one.There were no adverse consequences associated with this event and no further information was provided by hospital.

Manufacturer Narrative

Device evaluation: date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative.Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve and are attached.The position of the cam when valve was received was 100 mm h2o.The valve was hydrated for 24 hours.The valve was visually inspected: marks on the underside of the needle base were noted.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The catheters were irrigated, no occlusions noted.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The valve passed the test.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code ns9008 with lot crbcbw, conformed to the specifications when released to stock in 7th march 2014.No root cause could be determined, as the problem reported by the customer could not be duplicated the valve programmed.As noted in the ifu programming procedure in case of an inverted valve.The root cause for the marks on the underside of the needle base are probably caused by a needle.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: HAKIM VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6116785
• MDR Text Key: 60548643
• Report Number: 1226348-2016-10791
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: NS-9008
• Device Lot Number: CRBCBW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention